The short version
4 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Diazepam
Diazepam · DIAZEPAM 20 mg/4mL · Gel · Rectal · Navinta LLC
NDC 68475-0804-02 · 2 SYRINGE, PLASTIC in 1 PACKAGE / 4 mL in 1 SYRINGE, PLASTIC · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for diazepam (other) in the next 90 days
sole-source market · price up 4% YoY
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- analysis · manufacture · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA217468
- TE code
- AB
- Approval date
- Nov 14, 2025
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Diazepam (Gel)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Lupin Pharmaceuticals,Inc. | DIAZEPAM 20 mg/4g | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals,Inc. | DIAZEPAM 10 mg/2g | Jul 15, 2026 | Sep 2, 2026 |
| Navinta LLC | DIAZEPAM 2.5 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Navinta LLC | DIAZEPAM 10 mg/2mL | Jul 15, 2026 | Sep 2, 2026 |
| Navinta LLC | DIAZEPAM 20 mg/4mL | Jul 15, 2026 | Sep 2, 2026 |
| Oceanside Pharmaceuticals | DIAZEPAM 2.5 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
| Oceanside Pharmaceuticals | DIAZEPAM 10 mg/2mL | Jul 15, 2026 | Sep 2, 2026 |
| Oceanside Pharmaceuticals | DIAZEPAM 20 mg/4mL | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | DIAZEPAM 10 mg/2mL | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | DIAZEPAM 20 mg/4mL | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | DIAZEPAM 2.5 mg/.5mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Diazepam — NDC 68475-0804-02," retrieved September 3, 2026, https://drugdashboards.com/drug/68475080402.
Free to cite with attribution — see how the data is put together.